VerifyNow System recall
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care…
Why was VerifyNow System recalled?
The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Not available
- Product
- VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care…
- Recalling firm
- Accumetrics Inc
- Quantity
- 1,167 units total
- Distribution
- US Nationwide Distribution
- Recall date
- June 27, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)